Systems and methods facilitating reprocessing of surgical instruments

ABSTRACT

A method of sharpening a cutting edge of a knife of a surgical instrument includes manipulating an end effector assembly of a surgical instrument such that first and second jaw members of the end effector assembly are disposed in a spaced-apart position, retaining the first and second jaw members in the spaced-apart position, advancing a knife of the surgical instrument to an extended position wherein the knife extends between the first and second jaw members, retaining the knife in the extended position, and sharpening a cutting edge of the knife.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/960,849, filed on Apr. 24, 2018, the entire contents of which arehereby incorporated herein by reference.

BACKGROUND Technical Field

The present disclosure relates to surgical instruments and, moreparticularly, to systems and methods facilitating reprocessing ofsurgical instruments.

Background of Related Art

Multi-function surgical instruments are beneficial in that they allowmultiple surgical tasks to be performed with a single instrument,obviating the need to alternatingly remove and insert differentinstruments for performing different surgical tasks. However, in orderto provide additional functionality, additional components are addedthat must fit within the spatial and functional constraints of theinstrument. As a result, multi-function surgical instruments tend to berelatively complex in their design and manufacture.

Surgical instrument can generally be categorized as reusable instruments(e.g., instruments that are cleaned and/or sterilized), disposableinstruments (e.g., instruments that are entirely discarded after asingle use), and reposable instruments (e.g., instruments whereinportions are disposable and other portions are reusable after cleaningand/or sterilization). A new class of so called reprocessed instrumentshas recently been introduced by manufacturers. Typically, thesereprocessed instruments are disposable instruments (or reposableinstruments) that are collected after a surgical use and returned to amanufacturer where the instruments are disassembled,cleaned/disinfected, refurbished, re-assembled, sterilized and sold asreprocessed instruments. In many cases, most of the original parts of aninstrument are re-used to provide the necessary parts for reassembly ofthe same instrument. Parts that wear during use, are broken duringdisassembly, and/or are otherwise unable to be reprocessed as-is may berefurbished, modified, and/or alternatively replaced with replacementcomponents.

With respect to reprocessing of certain surgical instruments, such asmulti-function surgical instruments, efficient and effectivedisassembly, cleaning/disinfection, component replacement, componentrefurbishment, reassembly, and sterilization can be challenging. Thereis therefore a need for systems and methods facilitating reprocessing ofsurgical instruments.

SUMMARY

As used herein, the term “distal” refers to the portion that is beingdescribed that is further from a user, while the term “proximal” refersto the portion that is being described that is closer to a user.Further, to the extent consistent, any of the aspects described hereinmay be used in conjunction with any of the other aspects describedherein.

Provided in accordance with aspects of the present disclosure is amethod of sharpening a cutting edge of a knife of a surgical instrumentincluding manipulating an end effector assembly of a surgical instrumentsuch that first and second jaw members of the end effector assembly aredisposed in a spaced-apart position, maintaining the first and secondjaw members in the spaced-apart position, advancing a knife of thesurgical instrument to an extended position wherein the knife extendsbetween the first and second jaw members, retaining the knife in theextended position, and sharpening a cutting edge of the knife.

In an aspect of the present disclosure, the method further includespositioning the end effector assembly in a fixture prior to manipulatingthe end effector assembly.

In another aspect of the present disclosure, manipulating the endeffector assembly includes operably positioning a jack between the firstand second jaw members and actuating the jack to move the first andsecond jaw members to the spaced-apart position. The jack may further beconfigured to maintain the first and second jaw members in thespaced-apart position.

In still another aspect of the present disclosure, manipulating the endeffector assembly includes moving the first and second jaw members tothe spaced-apart position. In such aspects maintaining the first andsecond jaw members in the spaced-apart position includes positioning ajack between the first and second jaw members to maintain the first andsecond jaw members in the spaced-apart position.

In yet another aspect of the present disclosure, advancing the knifeincludes actuating the knife from a proximal end portion of a knifeassembly including the knife. Alternatively, advancing the knifeincludes pulling the knife distally.

In still yet another aspect of the present disclosure, retaining theknife in the extended position includes attaching a clamp to the knife.

In another aspect of the present disclosure, the method furtherincludes, prior to manipulating the end effector assembly, disassemblingthe surgical instrument such that a front end assembly including the endeffector assembly and the knife is removed from a remainder of thesurgical instrument.

In another aspect of the present disclosure, the method furtherincludes, before or after sharpening the cutting edge of the knife,flushing the front end assembly, e.g., with a cleaning solution, and/orreassembling the front end assembly with the remainder of the surgicalinstrument.

Another method of sharpening a cutting edge of a knife of a surgicalinstrument provided in accordance with aspects of the present disclosureincludes disassembling a surgical instrument to remove a front endassembly therefrom. The front end assembly includes an elongated shaftassembly, an end effector assembly disposed at a distal end of theelongated shaft assembly, and a knife operably disposed within theelongated shaft assembly. The method further includes manipulating theend effector assembly such that first and second jaw members of the endeffector assembly are disposed in a spaced-apart position, maintainingthe first and second jaw members in the spaced-apart position, advancingthe knife to an extended position wherein the knife extends between thefirst and second jaw members, retaining the knife in the extendedposition, and sharpening a cutting edge of the knife.

In an aspect of the present disclosure, the method further includespositioning the end effector assembly in a fixture prior to manipulatingthe end effector assembly.

In another aspect of the present disclosure, manipulating the endeffector assembly includes operably positioning a jack between the firstand second jaw members and actuating the jack to move the first andsecond jaw members to the spaced-apart position.

In yet another aspect of the present disclosure, manipulating the endeffector assembly includes manually moving the first and second jawmembers to the spaced-apart position.

In still another aspect of the present disclosure, maintaining the firstand second jaw members in the spaced-apart position includes positioninga jack between the first and second jaw members.

In still yet another aspect of the present disclosure, advancing theknife includes actuating the knife from a proximal end portion of aknife assembly including the knife. Alternatively, advancing the knifeincludes pulling the knife distally.

In another aspect of the present disclosure, the method furtherincludes, before or after sharpening the cutting edge of the knife,flushing the front end assembly, e.g., with a cleaning solution, and/orreassembling the front end assembly with the surgical instrument.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the present disclosure are described herein withreference to the drawings wherein like reference numerals identifysimilar or identical elements:

FIG. 1 is a perspective view of a multi-function surgical instrument;

FIG. 2 is an enlarged, perspective view of a distal end portion of thesurgical instrument of FIG. 1, wherein a deployable assembly thereof isdisposed in a retracted position;

FIG. 3 is an enlarged, perspective view of the distal end portion of thesurgical instrument of FIG. 1, wherein the deployable assembly isdisposed in a deployed position;

FIG. 4 is a perspective view of a proximal end portion of the surgicalinstrument of FIG. 1 with portions removed to illustrate the internalworking components thereof;

FIG. 5 is a perspective view of a front end assembly of the surgicalinstrument of FIG. 1, with portions thereof removed;

FIG. 6 is an enlarged, perspective view of the area of detail indicatedas “6” in FIG. 5; and

FIGS. 7A-7D are side views of a distal end portion of the front endassembly of FIG. 5 illustrating systems and methods for sharpening theknife thereof without requiring disassembly of the front end assembly.

DETAILED DESCRIPTION

Referring to FIG. 1, a multi-function surgical instrument provided inaccordance with the present disclosure is shown generally identified byreference numeral 10. Instrument 10 is configured to operate in both abipolar mode, e.g., for grasping, treating, and/or mechanicallydissecting tissue, and a monopolar mode, e.g., for treating and/orelectrically/electromechanically dissecting tissue. Although the presentdisclosure is shown and described with respect to instrument 10, thesystems and methods facilitating reprocessing provided in accordancewith the present disclosure are equally applicable for use with anysuitable surgical instrument or portion(s) thereof. Obviously, differentconsiderations apply to different instruments; however, the aspects andfeatures of the present disclosure remain generally consistentregardless of the particular instrument provided. For the purposesherein, instrument 10 is generally described.

With reference to FIGS. 1-6, instrument 10 generally includes a housing20, a handle assembly 30, a trigger assembly 60, a rotation assembly 70,an elongated shaft assembly 80, an end effector assembly 100, a driveassembly 140, a knife assembly 160, bipolar and monopolar activationassemblies 170, 180, respectively, a monopolar assembly 200, and adeployment and retraction mechanism 300. Rotation assembly 70, elongatedshaft assembly 80, end effector assembly 100, drive assembly 140, knifeassembly 160, and monopolar assembly 200 together form a front endassembly 400 of instrument 10 (see FIGS. 5 and 6).

Instrument 10 also includes an electrosurgical cable (not shown) thatconnects instrument 10 to a generator (not shown) or other suitablepower source. The electrosurgical cable includes wires (not shown)extending therethrough that have sufficient length to extend throughhousing 20 and/or elongated shaft assembly 80 in order to provide energyto at least one of the electrically-conductive surfaces 112, 122 of jawmembers 110, 120, respectively, of end effector assembly 100, e.g., uponactivation of bipolar activation switch 172 of bipolar activationassembly 170 in the bipolar mode of operation. Similarly, one or more ofthe wires of the electrosurgical cable extends through housing 20 and/orelongated shaft assembly 80 in order to provide energy to monopolarassembly 200, e.g., upon activation of either of the monopolaractivation switches 182 of monopolar activation assembly 180 in themonopolar mode of operation.

Elongated shaft assembly 80 extends distally from housing 20 andsupports end effector assembly 100 at a distal end thereof. End effectorassembly 100 includes opposing jaw members 110, 120 pivotably coupled toone another. Each of the jaw members 110, 120 includes anelectrically-conductive surface 112, 122 adapted to connect to thesource of energy and defines a bipolar configuration in use whereinsurface 112 is charged to a first electrical potential and surface 122is charged to a second, different electrical potential such that anelectrical potential gradient is created for conducting energy betweensurfaces 112, 122 and through tissue grasped therebetween for treatingtissue. Bipolar activation switch 172 of bipolar activation assembly 170(FIG. 1) is operably coupled between the source of energy (not shown)and surfaces 112, 122 via one or more wires (not shown), thus allowingthe surgeon to apply bipolar energy to surfaces 112, 122 of jaw members110, 120, respectively, of end effector assembly 100 during a bipolarmode of operation.

Handle assembly 30 includes a movable handle 40 and a fixed handle 50.Movable handle 40 is movable relative to fixed handle 50 between aninitial position, wherein movable handle 40 is spaced-apart from fixedhandle 50, and a compressed position, wherein movable handle 40 iscompressed towards fixed handle 50. Drive assembly 140 is operablycoupled between handle assembly 30 and end effector assembly 100 suchthat movement of movable handle 40 between the initial position and thecompressed position pivots jaw member 110 relative to jaw member 120between the spaced-apart position and the approximated position, to athreshold force, at which point movable handle 40 is decoupled from jawmember 110 such that jaw member 110 is maintained in position despitefurther movement of movable handle 40 towards the compressed position.More specifically, when the threshold force is reached, a compressionspring 142 (FIG. 6) of drive assembly 140 is compressed, decouplingmovable handle 40 from jaw member 110 and allowing further movement ofmovable handle 40 towards the compressed position without impacting theposition of jaw member 110. The threshold force is the force at whichthe drive force exceeds the spring compression force of compressionspring 142. Thus, when the drive force is less than or equal to thespring compression force of compression spring 142, movement of movablehandle 40 between the initial position and the compressed positionpivots jaw member 110 relative to jaw member 120 between thespaced-apart position and the approximated position. On the other hand,when the drive force exceeds the spring compression force of compressionspring 142, jaw member 110 is maintained in position and compressionspring 142 is further compressed in response to movement movable handle40 towards the compressed position.

Continuing with reference to FIGS. 1-4, trigger 62 of trigger assembly60 is selectively actuatable relative to housing 20 from an un-actuatedposition to an actuated position. Knife assembly 160 is operably coupledto trigger 62 such that actuation of trigger 62 from the un-actuatedposition to the actuated position translates a knife 162 (FIGS. 7B-7D)of knife assembly 160 from a retracted position, wherein knife 162 isdisposed proximally of jaw members 110, 120, to an extended position,wherein knife 162 extends at least partially between jaw members 110,120 and through knife channels (not shown) defined within jaw members110, 120 such that cutting edge 164 of knife 162 cuts tissue graspedbetween jaw members 110, 120. Movable handle 40 may include a protrusion42 acting as a knife lockout to inhibit actuation of trigger 62 whenmovable handle 40 is disposed in the initial position, although othersuitable knife lockouts operably coupled between trigger 62 and movablehandle 40 are also contemplated.

Rotation of rotation wheel 72 of rotation assembly 70 relative tohousing 20 effects corresponding rotation of at least a portion ofelongated shaft assembly 80, end effector assembly 100, drive assembly140, the knife assembly 160, and monopolar assembly 200 relative tohousing 20.

Monopolar assembly 200 includes an insulative sheath 210 and anenergizable member 220. Insulative sheath 210 is movable relative to endeffector assembly 100 between a storage position, wherein insulativesheath 210 is disposed proximally of end effector assembly 100, and ause position, wherein insulative sheath 210 is substantially disposedabout end effector assembly 100. Energizable member 220 is coupled tothe source of energy (not shown) and monopolar activation assembly 180(FIG. 1) via one or more wires (not shown) and functions as the activeelectrode of monopolar assembly 200. Energizable member 220 is movabletogether with insulative sheath 210 and relative to end effectorassembly 100 between a storage position, wherein distal tissue-treatingportion 227 of energizable member 220 is positioned more-proximally, anda use position, wherein distal tissue-treating portion 227 ofenergizable member 220 extends distally from end effector assembly 100to facilitate treating tissue therewith. Energizable member 220, morespecifically, is engaged with insulative sleeve 210 such thatenergizable member 220 and insulative sleeve 210 move together betweentheir respective storage and use positions (collectively the storage anduse positions of monopolar assembly 200). In the use position,insulative sheath 210 serves to electrically insulate end effectorassembly 100 from distal tissue-treating portion 227 of energizablemember 220, while distal tissue-treating portion 227 extends distallyfrom end effector assembly 100. In the use position, energy may besupplied to distal tissue-treating portion 227 of energizable member220, e.g., via activation of either of the activation switches 182 ofmonopolar activation assembly 180 (FIG. 1), for treating tissue in themonopolar mode of operation.

Deployment and retraction mechanism 300 is configured for selectivelytransitioning monopolar assembly 200 between its storage condition andits use condition. Deployment and retraction mechanism 300 generallyincludes a gear box 310 mounted within housing 20, a gear assembly 320operably disposed within gear box 310, a pair of input shafts 330operably coupled to gear assembly 320 and extending transversely fromeither side of gear box 310 and outwardly from housing 20 throughapertures defined through housing 20, a pair of deployment paddles 340operably coupled to the input shafts 330, and a slider 360 disposedwithin housing 20 and operably coupling an output of gear assembly 330with energizable member 220 of monopolar assembly 200 (which, in turn,is engaged with insulative sleeve 210) such that deployment andretraction mechanism 300 is configured to enable both deployment andretraction of monopolar assembly 200 in a push-push manner, e.g.,wherein monopolar assembly 200 is both deployed and retracted by pushingeither of paddles 340 in the same direction.

Referring to FIGS. 4-6, with regard to the disassembly,cleaning/disinfection, re-assembly, and sterilization of instrument 10during reprocessing, the various components and assemblies of instrument10 and the arrangement thereof make disassembling and re-assembling timeconsuming and challenging. Therefore, avoiding the need to disassembleportions of instrument 10 is advantageous, assuming the components ofthese portions to remain in-tact can be readily reconditioned andsterilized for reuse. With respect to knife 162 (FIGS. 7B-7D), forexample, it has been found that cutting edge 164 may dull during use,thus requiring sharpening as part of reprocessing instrument 10.Provided below are systems and methods enabling sharpening of cuttingedge 164 of knife 162 without requiring disassembly of front endassembly 400 of instrument 10. As such, the disassembly and re-assemblyof front end assembly 400 during reprocessing is obviated.

In order to reprocess instrument 10, in embodiments, paddles 340 ofdeployment and retraction mechanism 300 (FIG. 1) are removed, housing 20is opened, and the various components therein are removed. Morespecifically, the various components coupled to front end assembly 400may be decoupled therefrom to enable front end assembly 400 to beremoved as a unit. With front end assembly 400 removed from instrument10, cutting edge 164 of knife 162 may be sharpened, as detailed below,without disassembly of front end assembly 400. In embodiments, insteadof separating front end assembly 400 from instrument 10, cutting edge164 of knife 162 may be sharpened similarly as detailed below whileinstrument 10 is fully in-tact or partially disassembled (with front endassembly 400 still assembled therewith).

Turning to FIGS. 7A-7D, and with initial reference to FIG. 7A, in orderto sharpen cutting edge 164 of knife 162 without removing knife 162 fromfront end assembly 400, front end assembly 400, or at least end effectorassembly 100 thereof, is placed in a fixture 500 to retain end effectorassembly 100 in position. Thereafter, jaw members 110, 120 of endeffector assembly 100 are moved to the spaced-apart position and a jack510 is positioned to maintain jaw members 110, 120 in the spaced-apartposition. Jack 510 may include a base 512 engaged with or otherwisedisposed on fixture 500, a shaft 514 extending from base 512, and asupport 516 disposed at the opposite end of shaft 514 for abutting jawmember 110 to maintain jaw member 110 in the spaced-apart position. Jack510 may be a stationary fixture or an adjustable fixture. Jaw members110, 120 may be manually opened and jack 510 thereafter positioned tomaintain jaw members 110, 120 in the spaced-apart position, or support516 of jack 510 may be positioned between jaw members 110, 120 and jack510 thereafter actuated (in embodiments where jack 510 is adjustable) toelongate shaft 514 to urge jaw member 110 to pivot relative to jawmember 120 to the spaced-apart position, similar to a car jack. In theformer embodiments, jack 510 need not be adjustable and may insteadsimply be a support structure for maintaining jaw members 110, 120 inthe spaced-apart position. Other configurations are also contemplated.

Referring to FIG. 7B, with fixture 500 retaining end effector assembly100 and jack 510 maintaining jaw member 110 in the spaced-apartposition, knife 162 is moved to the extended position. Knife 162 may bemoved to the extended position using a grasping device 520 coupled to apull wire 522, as shown, may be moved to the extended position bymanipulating knife assembly 160 at the proximal end 165 thereof (seeFIG. 6), or may be moved to the extended position in any other suitablemanner.

With reference to FIG. 7C, once knife 162 is moved to the extendedposition, a clamp 530 may be engaged with knife 162 at a positionproximally-spaced from cutting edge 164. Clamp 530 may also be engagedwith shaft 514 of jack 510, as shown, fixture 500, or any other suitablecomponent to maintain knife 162 in the extended position.

Turning to FIG. 7D, with end effector assembly 100 retained, jaw members110, 120 disposed in the spaced-apart position, and knife 162 held inthe extended position, a knife sharpener 540 may be moved into positionto sharpen cutting edge 164 of knife 162. Knife sharpener 540 may be ajig-assisted sharpener, sharpening stone-based sharpener, push-throughsharpener, grinder sharpener, belt sharpener, or other suitable knifesharpener and may be manually operated or powered.

Referring again to FIGS. 7A-7D, once cutting edge 164 of knife 162 issufficiently sharpened, clamp 530 and jack 510 are removed and endeffector assembly 100 withdrawn from fixture 500. Thereafter, front endassembly 400 may be flushed with a suitable fluid, e.g., a cleaningsolution, to clean front end assembly 400 and remove any debris from thesharpening process. In embodiments, front end assembly 400 mayadditionally or alternatively be flushed with a suitable fluid, e.g., acleaning solution, prior to sharpening knife 162 to rid any tissue,blood, and/or other debris accumulated during the previous surgical use,before the sharpening process is performed as detailed above. Front endassembly 400 may further be cleaned, refurbished, and/or otherwisereprocessed, before being re-assembled into instrument 10 andsterilized.

Referring generally to FIGS. 1-7D, in embodiments, sharpening of cuttingedge 164 of knife 162 is effected without requiring disassembly of frontend assembly 400 from housing 20, handle assembly 30, or triggerassembly 60 and, in embodiments, without requiring any disassembly (orminimal disassembly) of instrument 10. In such embodiments, instrument10 is placed in fixture 500 to retain end effector assembly 100 inposition and movable handle 40 is moved to the initial position to movejaw members 110, 120 of end effector assembly 100 to the spaced-apartposition. Thereafter, jack 510 is positioned to maintain jaw members110, 120 in the spaced-apart position. Next, movable handle 40 is movedto the compressed position or sufficiently to the compressed positionsuch that the knife lockout, e.g., protrusion 42, is cleared and, thus,trigger 62 may be actuated to advance knife 162 to the extendedposition. More specifically, with jack 510 maintaining jaw members 110,120 in the spaced-apart position, movable handle 40 is moved towards thecompressed position with sufficient force to reach the threshold forcesuch that compression spring 142 (FIG. 6) is compressed, thus allowingmovement of movable handle 40 towards the compressed position withoutimpacting the position of jaw members 110, 120 which, as noted above,are maintained in the spaced-apart position via jack 510. Movable handle40 is maintained, e.g., manually held, latched (with a separate latchingdevice or, in embodiments where so provided, a latch incorporated intoinstrument 10), or otherwise retained, in the compressed or sufficientlycompressed position so as to maintain the knife lockout in a disengagedstate.

Next, trigger 62 is actuated (which is permitted, despite jaw members110, 120 being in the spaced-apart position, since the knife lockout hasbeen cleared, as detailed above), to advance knife 162 to the extendedposition. Knife 162 may be maintained in the extended position viamanually holding trigger 62 in the actuated position, latching (with aseparate latching device), otherwise retaining trigger 62, or by holdingknife 162, similarly as detailed above. Thereafter, cutting edge 164 ofknife 162 may be sharpened similarly as detailed above.

From the foregoing and with reference to the various drawing figures,those skilled in the art will appreciate that certain modifications canalso be made to the present disclosure without departing from the scopeof the same. While several embodiments of the disclosure have been shownin the drawings, it is not intended that the disclosure be limitedthereto, as it is intended that the disclosure be as broad in scope asthe art will allow and that the specification be read likewise.Therefore, the above description should not be construed as limiting,but merely as exemplifications of particular embodiments. Those skilledin the art will envision other modifications within the scope and spiritof the claims appended hereto.

What is claimed is:
 1. A system for sharpening a cutting edge of a knife of a surgical instrument, the system comprising: a jack configured to retain first and second jaw members of an end effector assembly of a surgical instrument in a spaced-apart position relative to one another; a clamp configured to retain a knife of the surgical instrument in an extended position wherein the knife extends between the first and second jaw members in the spaced-apart position thereof; and a sharpener configured to sharpen a cutting edge of the knife while the jack retains the first and second jaw members in the spaced-apart position and the clamp retains the knife in the extended position.
 2. The system according to claim 1, further comprising a fixture configured to receive and retain at least a portion of the end effector assembly therein.
 3. The system according to claim 2, wherein the fixture is configured to receive and retain one of the first or second jaw members in fixed position therein.
 4. The system according to claim 2, wherein the clamp is configured to engage the fixture to retain the clamp in position.
 5. The system according to claim 1, wherein the jack includes a base, a shaft, and a support, the support configured to engage one of the first or second jaw members to retain the first and second jaw members in the spaced-apart position.
 6. The system according to claim 5, wherein the support is slidable along the shaft and relative to base to move the one of the first or second jaw members to thereby move the first and second jaw members to the spaced-apart position.
 7. The system according to claim 1, wherein the clamp is configured to engage the knife at a position spaced-apart from the cutting edge of the knife.
 8. The system according to claim 7, wherein the position is proximally spaced-apart from the cutting edge of the knife.
 9. The system according to claim 1, further comprising a grasping device configured to grasp the knife to enable pulling of the knife to the extended position.
 10. The system according to claim 9, further comprising a pull-wise connected to the grasping device, wherein the pull wire is actuatable to pull the knife to the extended position.
 11. The system according to claim 1, wherein the sharpener is manually operated.
 12. The system according to claim 1, wherein the sharpener is powered.
 13. The system according to claim 1, wherein the sharpener is one of: a jig-assisted sharpener, a sharpening stone-based sharpener, a push-through sharpener, a grinder sharpener, or a belt sharpener.
 14. The system according to claim 1, wherein the sharpener is movable from a first position, wherein the sharpener is spaced-apart from the knife, to a second position, wherein the sharpener is adjacent the cutting edge of the knife to enable sharpening thereof.
 15. The system according to claim 1, wherein the clamp is configured to engage the jack to retain the clamp in position. 